Bardex® Lubricath® Foley Catheter Hotter Model 6003L22Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741018886), received between Nov 7, 2025 and Feb 26, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Inaccurate Flow Rate

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461048 ↗
• MalfunctionFeb 26, 2026Inaccurate Flow Rate

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461047 ↗
• MalfunctionFeb 26, 2026Inaccurate Flow Rate

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456402 ↗
• MalfunctionFeb 26, 2026Complete Blockage

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456401 ↗
• MalfunctionFeb 26, 2026Inaccurate Flow Rate

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456400 ↗
• MalfunctionFeb 26, 2026Inaccurate Flow Rate

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

  Patient problems: Discomfort; Pain

  MAUDE report 24456026 ↗
• InjuryNov 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE SILICONE URINARY CATHETER BALLOON NUMBER 22 APPEARS TO HAVE BURST INSIDE THE BLADDER, CAUSING IT TO BE REMOVED IMMEDIATELY. ONCE ANALYZED AND TESTED, THE BALLOON WITH A 30 ML CAPACITY WAS INDEED FOUND TO BE NON-EXISTENT. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 06FEB2026, IT WAS REPORTED THAT SOME INFORMATION WAS MISSING, BUT THE FOLLOWING DETAILS HAD BEEN RECEIVED. THE BALLOON OF THE URINARY CATHETER, 3-WAY PORGES 100% SILICONE URINARY CATHETER, SIZE 22, 50 ML, LOT 09698842 APPEARED TO HAVE BURST INSIDE THE BLADDER, RESULTING IN ITS IMMEDIATE REMOVAL. UPON ANALYSIS AND TESTING, THE BALLOON WAS CONFIRMED TO BE MISSING. THE COMPLETE MEMBRANE OF THE INFLATED BALLOON WITH 30 ML FOR THE SAME 3-WAY PORGES 100% SILICONE URINARY CATHETER, SIZE 22, 50 ML, LOT 09698842, WAS NOT FOUND AND WAS PRESUMED TO BE INSIDE THE PATIENT¿S BLADDER. THE UROLOGIST HAD BEEN CONTACTED, BUT THE FOLLOW UP FROM THAT CONSULTATION WAS NOT AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23572954 ↗
• MalfunctionNov 7, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT URINARY FOLEY CATHETER INSERTED ACCORDING TO PROPER TECHNIQUE WITH 10 ML IN THE BALLOON NO DRAINAGE, IRRIGATION POSSIBLE. CATHETER REMOVED. SECOND CATHETER INSERTED NO DRAINAGE IRRIGATION POSSIBLE; WHEN STAFF ATTEMPT TO REMOVE THE WATER FROM THE BALLOON, CATHETER COLLAPSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501367 ↗